Drugs

FDA Panel Votes Down Pacira sNDA for Pain Blocker

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee has voted 6 to 4 to not recommend approval of a Pacira Pharmaceuticals supplemental NDA for Exparel (bupivacaine liposome injectable suspension) and its use as a nerve block to produce regional analgesia. The six panel members agreed that more research data are needed to further support the proposed indication. The user fee review action target date is 4/6. Exparel is currently indicated for infiltration into the surgical site to produce postsurgical analgesia.

The company says the submission is based on data from a Phase 3 study of Exparel in femoral nerve block for total knee arthroplasty and a Phase 3 study in brachial plexus block for shoulder surgeries. It also includes data from eight company-sponsored studies with safety and pharmacokinetic data through 120 hours, and data from two investigator-initiated studies that provide additional experience in smaller, peripheral nerve block settings.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome